1. Field of the Invention
This patent application pertains to medical drapes, and more specifically, pertains to fenestrated surgical drapes. Even more specifically, this patent application relates to fenestrated surgical drapes that allow for removal of the drape from a patent following surgery without first requiring removal of tubes or catheters from the patient.
2. Background
Medical drapes are used in various applications in operating rooms, cardiac catheterization departments and other departments throughout healthcare facilities. The main purpose of the medical drapes is to provide a sterile field about the surgical site and to cover the patient during an invasive procedure. Typical surgical drapes have one or more openings or windows commonly known in the medical field as a “fenestrated incision site.”
Medical drapes are intended to maintain a sterile field around a fenestrated incision site, maintaining a barrier that minimizes the passage of microorganisms between the non-sterile and sterile areas. Fenestrated medical drapes are commonly made of disposable nonwoven fabrics, plastic polymeric film or perforated papers all of which surround the incision site.
Current problems with medical drapes occur during the removal of the soiled medical drape where medical apparatus such as wires, tubes, blood pumps, and the like, remain in the patient after a medical procedure is performed. Because such medical apparatus is received into the body through the apertures in the surgical drape, it is a problem to remove the drape after the procedure has been completed. Although the base sheet is often made of an easy-to-tear material, the stronger plastic polymeric film or absorbent pads usually require the use of scissors or perforations to be remove the drape from the patient. Obviously, the preferred medical practice is to avoid the use of scissors to remove the surgical drape. Existing designs to solve this problem of drape removal is to use perforations in the various components of the drape. Perforations help to make removal easier but in doing so the perforations compromise the sterile field protection that the drape is designed to offer.
Others have tried to solve the drape removal problem mainly by either using specialized perforations or by leaving the polymer layer unperforated. However, while the unperforated polymer layer does give protection and provides a barrier against micro-organisms, the lack of perforations makes removal of the drape difficult. The use of perforations solves the problem of easy removal of the drape, but compromises the sterile field protection because there are holes made in the drape.
U.S. Pat. No. 5,975,082 issued to Dowdy discloses a tear away surgical drape with an opening surrounded by a perforated absorbent pad. The drape and pad have a perforated score line for tearing away the pad after surgery. The tear-away perforation allows the drape to be torn and removed without use of scissors and without the need of removing the tube or catheter from the patient. However, the perforations destroy the sterile field between the drape and the environment and increase risks for contamination and infection.
U.S. Pat. Nos. 6,286,511 and 6,405,730 both issued to Levitt et al. provide an ophthalmic drape having integral, perforated tear lines. The drape has a fenestration for allowing access to the eye, with an absorbent pad encircling the opening. One set of tear lines permits the drape to be torn in two halves while an alternative set of tear lines are set at an oblique angle to tear out a small portion of the drape. The Levitt patents are similar to the Dowdy patent discussed above as each discuss a drape having perforated tear lines. As such, the perforations destroy the sterile field between the drape and the environment and increase risks for contamination and infection.
United States patent application publication number 2010/0031966 to Allen provides a medical drape having a score line between a fenestration and the outer edge of the drape. The score line is secured using an adhesive strip. After use, the adhesive strip is removed exposing the score line. The score line allows separation of the two halves of the drape such that a catheter or tube does not have to be removed from the patient after surgery or treatment. The Allen application is another variation of a tear-away drape. Importantly, the Allen drape is split and reattached before use thereby increasing production time and cost as more materials and production steps are needed to produce the final device. Moreover, the additional steps and materials increase the risk of contamination. Furthermore, the removal of the adhesive material may cause the adhesive strip to contact and stick to the drape, patient, or other materials leading to dangerous conditions in the surgical or treatment area.
Thus, it is readily apparent that there is a long-felt need for a sterile, non-perforated fenestrated surgical drape which can be easily removed from a patient's body after completion of a surgical procedure.
The present invention seeks to alleviate the problems associated with the fenestrated surgical drapes that allow for removal of the drape from a patent following surgery without first requiring removal of tubes or catheters from the patient and to provide a device that maintains a sterile field between the patient and the environment.